Amgen: FDA gets Neulasta label expansion OK

KatherineHunt

SAN FRANCISCO (MarketWatch) -- Amgen Inc.
AMGN, -0.03%
said after the closing bell on Thursday that the Food and Drug Administration has approved an expansion to its Neulasta prescribing information to include data from a Phase III study. The study demonstrated that the white blood cell booster helps to protect patients with most types of cancer undergoing moderately myelosuppressive chemotherapy from infection, as manifested by low white blood cell count with fever, known as febrile neutropenia, Amgen said. Febrile neutropenia is one of the most serious side effects of chemotherapy. Administration of Neulasta beginning in the first cycle of chemotherapy is now approved for patients receiving myelosuppressive chemotherapy associated with at least a 17% risk of febrile neutropenia, the company said. It was previously used for patients with more than 30% to 40% risk of febrile neutropenia.

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